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Project to be led by Dr. Valentin Fuster of the Mount Sinai Medical Center and funded by $25 million NIH grant

How does diabetes impact cardiovascular disease? What type of surgical intervention is best for diabetics with cardiovascular disease? Is there one surgery that is best for all? When should expensive drug-eluting stents be used? These are just a few of the questions to be addressed by the Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM) trial.

This trial is being funded by a $25 million grant from the National Heart, Lung and Blood Institute of the National Institutes of Health (NHLBI) to Dr. Valentin Fuster MD, PhD, the Director of the Zena and Michael A. Wiener Cardiovascular Institute and of the Marie-Josée and Henry R. Kravis Cardiovascular Health Center of The Mount Sinai Medical Center. "This new program will reach far beyond the confines of any single institution or study," Dr. Fuster. "Our findings, the consortium we are building and the registry we will create will serve as a foundation upon which numerous NIH funded studies will be based in the coming years. These studies will focus on the impact of cardiovascular disease in diabetics and the development of new approaches to management and treatment of both diseases."

Diabetes is an emerging epidemic in the US. There are currently 16 million confirmed cases and another 20 million patients are known to be at high risk. Eighty percent of all deaths among diabetic patients are due to coronary artery disease, compared to about 30% among non-diabetic patients. "It is imperative that we act now to understand the interrelationship of these diseases and to analyze the comparative benefits of the burgeoning number of treatment options," said Dr. Fuster.

The most widely used surgical treatments for coronary artery disease are Coronary Artery Bypass Grafting (CABG) and balloon angioplasty. Trials in the early 1990's indicated no difference in benefit from the two procedures for the general population, but did indicate benefits of CABG for diabetics. Based on these studies, NIH issued a clinical alert in 1995 recommending the use of CABG over balloon angioplasty for diabetics. Recent reports show that this alert has had little effect on actual practice.

Dr. Fuster notes, "By the time this alert was issued major advances had occurred in the two surgical approaches, so these studies conducted with older approaches were rapidly outdated." For example, in the clinical trials upon which NIH based their 1995 alert, stents were not inserted after angioplasty to prevent the vessel from closing again. Today, doctors not only routinely insert stents, they also coat these stents with drugs to reduce the build up of damaging plaque in the vessel.

With the recent FDA approval of drug-eluting stents, it is more pressing than ever that clear guidelines be developed as to what procedures are best for which patients. Doctors need to know if these stents work equally well in all patients? Are equally safe for all patients? Would some patients do just as well with the far less expensive non-coated stents? And, many other related questions.

"Both CABG and angioplasty present potential risks and benefits to patients," said Dr. Kenneth Davis, MD, President and CEO of The Mount Sinai Medical Center and Dean of Mount Sinai School of Medicine. "Only with large-scale, carefully planned and executed studies such as those that will be conducted by Dr. Fuster and his colleagues can we determine the best approach for each individual."

In addition to the 2,400 patients that will be recruited for the trial, the researchers will also recruit 2,000 patients to be part of a registry to be used to for analysis that will broaden the scope of the trial to the population of diabetic patients with coronary artery disease. FREEDOM will bring together a broad coalition of academic medical centers.